Carcinoma, Renal Cell Clinical Trial
Official title:
A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)
| Verified date | August 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This trial has two parts. The purpose of the first part of the trial is to determine the
doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in
combination. This part is currently closed to enrollment.
The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2
schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying
progression of renal cell cancer than sunitinib malate given on a continuous dosing
schedule. The trial will also determine the number of patients whose cancer responds to the
treatments, whether life of patients can be extended, what the side effects are of the
treatments, how bothersome disease or treatment-related symptoms are to patients, and
whether tests can be found that will predict which patients may or may not respond to these
treatments in the future.
| Status | Completed |
| Enrollment | 317 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology. - Measurable disease Exclusion Criteria: - Prior systemic therapy of any kind for advanced renal cell cancer - History of brain metastases - Uncontrolled hypertension |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Amsterdam | New York |
| United States | Pfizer Investigational Site | Anaheim | California |
| United States | Pfizer Investigational Site | Aurora | Colorado |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Baldwin Park | California |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
| United States | Pfizer Investigational Site | Bedford | Texas |
| United States | Pfizer Investigational Site | Bellflower | California |
| United States | Pfizer Investigational Site | Bethesda | Maryland |
| United States | Pfizer Investigational Site | Boca Raton | Florida |
| United States | Pfizer Investigational Site | Boise | Idaho |
| United States | Pfizer Investigational Site | Boulder | Colorado |
| United States | Pfizer Investigational Site | Boulder | Colorado |
| United States | Pfizer Investigational Site | Brockport | New York |
| United States | Pfizer Investigational Site | Canadaigua | New York |
| United States | Pfizer Investigational Site | Canton | Ohio |
| United States | Pfizer Investigational Site | Cary | North Carolina |
| United States | Pfizer Investigational Site | Cedar Rapids | Iowa |
| United States | Pfizer Investigational Site | Chesapeake | Virginia |
| United States | Pfizer Investigational Site | Clinton | North Carolina |
| United States | Pfizer Investigational Site | Colorado Springs | Colorado |
| United States | Pfizer Investigational Site | Columbus | Georgia |
| United States | Pfizer Investigational Site | Columbus | Georgia |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Corpus Christi | Texas |
| United States | Pfizer Investigational Site | Covington | Louisiana |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Delray Beach | Florida |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Duarte | California |
| United States | Pfizer Investigational Site | Dunmore | Pennsylvania |
| United States | Pfizer Investigational Site | Easley | South Carolina |
| United States | Pfizer Investigational Site | Elizabeth City | North Carolina |
| United States | Pfizer Investigational Site | Elkhart | Indiana |
| United States | Pfizer Investigational Site | Eugene | Oregon |
| United States | Pfizer Investigational Site | Farmington | New Mexico |
| United States | Pfizer Investigational Site | Fontana | California |
| United States | Pfizer Investigational Site | Fort Worth | Texas |
| United States | Pfizer Investigational Site | Geneva | New York |
| United States | Pfizer Investigational Site | Georgetown | Texas |
| United States | Pfizer Investigational Site | Goldsboro | North Carolina |
| United States | Pfizer Investigational Site | Grand Rapids | Michigan |
| United States | Pfizer Investigational Site | Greenville | South Carolina |
| United States | Pfizer Investigational Site | Greenville | South Carolina |
| United States | Pfizer Investigational Site | Gretna | Louisiana |
| United States | Pfizer Investigational Site | Hackensack | New Jersey |
| United States | Pfizer Investigational Site | Hampton | Virginia |
| United States | Pfizer Investigational Site | Henderson | Nevada |
| United States | Pfizer Investigational Site | Hickory | North Carolina |
| United States | Pfizer Investigational Site | Holland | Michigan |
| United States | Pfizer Investigational Site | Hot Springs | Arkansas |
| United States | Pfizer Investigational Site | Hudson | New York |
| United States | Pfizer Investigational Site | Irvine | California |
| United States | Pfizer Investigational Site | Jefferson | Indiana |
| United States | Pfizer Investigational Site | Kokomo | Indiana |
| United States | Pfizer Investigational Site | La Porte | Indiana |
| United States | Pfizer Investigational Site | Lakeland | Florida |
| United States | Pfizer Investigational Site | Lakewood | Colorado |
| United States | Pfizer Investigational Site | LaPorte | Indiana |
| United States | Pfizer Investigational Site | LaPorte | Indiana |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Latham | New York |
| United States | Pfizer Investigational Site | Lemoyne | Pennsylvania |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Littleton | Colorado |
| United States | Pfizer Investigational Site | Lone Tree | Colorado |
| United States | Pfizer Investigational Site | Longmont | Colorado |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Madison | Wisconsin |
| United States | Pfizer Investigational Site | Marrero | Louisiana |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Michigan City | Indiana |
| United States | Pfizer Investigational Site | Morgantown | West Virginia |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Newark | Delaware |
| United States | Pfizer Investigational Site | Newark | Delaware |
| United States | Pfizer Investigational Site | Newport News | Virginia |
| United States | Pfizer Investigational Site | Newport News | Virginia |
| United States | Pfizer Investigational Site | Niles | Michigan |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| United States | Pfizer Investigational Site | Norman | Oklahoma |
| United States | Pfizer Investigational Site | Norwich | Connecticut |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Orlando | Florida |
| United States | Pfizer Investigational Site | Panorama City | California |
| United States | Pfizer Investigational Site | Parker | Colorado |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Plymouth | Indiana |
| United States | Pfizer Investigational Site | Pueblo | Colorado |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Rexford | New York |
| United States | Pfizer Investigational Site | Riverside | California |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Round Rock | Texas |
| United States | Pfizer Investigational Site | Saint Joseph | Michigan |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Scranton | Pennsylvania |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seneca | South Carolina |
| United States | Pfizer Investigational Site | Shelbyville | Kentucky |
| United States | Pfizer Investigational Site | Shreveport | Louisiana |
| United States | Pfizer Investigational Site | South Bend | Indiana |
| United States | Pfizer Investigational Site | South Bend | Indiana |
| United States | Pfizer Investigational Site | Spartanburg | South Carolina |
| United States | Pfizer Investigational Site | Springfield | Oregon |
| United States | Pfizer Investigational Site | St. Joseph | Michigan |
| United States | Pfizer Investigational Site | St. Joseph | Michigan |
| United States | Pfizer Investigational Site | St. Joseph | Michigan |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Thorton | Colorado |
| United States | Pfizer Investigational Site | Troy | New York |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tyler | Texas |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | Washington | Missouri |
| United States | Pfizer Investigational Site | Webster | Texas |
| United States | Pfizer Investigational Site | Williamsburg | Virginia |
| United States | Pfizer Investigational Site | Wilmington | Delaware |
| United States | Pfizer Investigational Site | Wilson | North Carolina |
| United States | Pfizer Investigational Site | Woodland Hills | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44. | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | No |
| Secondary | Percentage of Participants With Objective Response (OR) | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | No |
| Secondary | Duration of Response (DR) | Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | No |
| Secondary | Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model | MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44. | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | No |
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